The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.

The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

The G6 hasn’t been tested in those situations. The magnetic fields and heat could damage the components of the G6, which may cause it to display inaccurate G6 sensor glucose readings (G6 readings) or may prevent alerts. Without G6 readings or alarm/alert notifications, you might miss a severe low or high glucose event.

Warnings

Read User Materials Before you use your G6, carefully read the materials included with it. If you don’t, you might:

No Number, No Arrow, No CGM Treatment Decision If your G6 doesn’t show a number or arrow, or your readings don’t match your symptoms, use your meter to make diabetes treatment decisions. No number, no arrow, no treatment decision. When in doubt, get your meter out.

Don’t Use If… Do not use the G6 if you are pregnant, on dialysis, or critically ill. It is not known how different conditions or medications common to theses populations may affect performance of the system. G6 readings may be inaccurate in these populations.

PrecautionAvoid Sunscreen and Insect Repellent Some skin care products, such as sunscreens and insect repellents, can make the plastic used in your G6 crack. Before using your G6, make sure there are no cracks in your receiver, transmitter, and transmitter holder. If you find a crack, please contact Technical Support. Do not allow these skin care products to contact your G6. After using skin care products, wash your hands before touching your G6. If any skin care products get on your G6, immediately wipe with a clean cloth.

Start Up Safety Statements

WarningsUse Meter During Startup When you start a new sensor, you won’t get any readings or alarm/alerts until you enter your sensor code or two calibrations. Use your meter to make treatment decisions during the 2-hour sensor warmup period. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Precautions

Use Correct Sensor Code When you start a new sensor, you must enter a code into your display device to use the G6 without fingerstick calibrations. Each sensor has its own code printed on the back of the adhesive patch. Do not use a code from a different sensor or make up a code. If you do not enter the correct code, your sensor will not work as well and could be inaccurate. If you lost the sensor code, you may calibrate the G6 using fingersticks. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Calibration Safety Statements

Calibration is not required if users enter a sensor code. If users do not enter a sensor code, the following warnings and precautions apply.

WarningsDon’t Wait – Calibrate! If you have not used the calibration code, you must manually calibrate your G6 using values obtained from a blood glucose meter and fingersticks daily. You must calibrate immediately when the G6 notifies you. If you haven’t calibrated when notified, your G6 may not be accurate, so use your glucose meter to make treatment decisions until you calibrate your G6.

Use Fingersticks Use fingertips to calibrate from your BG meter. Blood from other places may be less accurate and not as timely. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

PrecautionsBe Accurate, Be Quick. Enter the exact BG value displayed on your meter within five minutes of using your meter. Don’t enter the G6 reading as a calibration. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

System/Hardware/Software Safety Statements

WarningsWire Breaks Off Don’t ignore broken or detached sensor wires. A sensor wire could remain under your skin. If this happens, please contact our 24/7 Technical Support. If a sensor wire breaks off under your skin and you can’t see it, don’t try to remove it. Contact your HCP. Also seek professional medical help if you have symptoms of infection or inflammation – redness, swelling, or pain – at the insertion site.

Where to Insert: Belly or Buttocks? All patients can use their bellies (abdomen). Patients 2 to 17 years old can also choose their upper buttocks. Look for a place on your belly or upper buttocks where you have some padding. The sensor is not tested or approved for other sites. Talk to your HCP about the best site for you.

Where to Store You can store your sensors at room temperature or in your refrigerator – as long as it’s between 36° F and 86° F. Don’t store sensors in the freezer. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

PrecautionsDon’t Use if Expired Don’t use expired sensors, because they may give incorrect results. Check the package label for the expiration date. It’s in YYYY-MM-DD (Year-Month-Day) format.

Check Package Don’t use sensor if its sterile package has been damaged or opened, because it might cause an infection.

Clean and Dry Skin Clean and dry your hands and your insertion site before inserting your sensor. Wash your hands with soap and water, not gel cleaners, and then dry them before opening the sensor package. If your hands are dirty when you insert the sensor, you may get germs on the insertion site and get an infection. Clean your insertion site with alcohol wipes to prevent infections. Don’t insert the sensor until your skin is dry. If your insertion site is not clean and completely dry, you run the risk of infection or the transmitter holder not sticking well. Make sure you don’t have insect repellent, sunscreen, perfume, or lotion on your skin.

Where to Insert: Things to Check Keep the safety guard on until you put the G6 applicator against your skin. If you remove the safety guard first, you may hurt yourself by accidentally pushing the button that inserts the sensor before you mean to. Change your insertion site with each sensor. Using the same site too often might not allow the skin to heal, causing scarring or skin irritation. Sensor placement is important. Choose a site: • At least 3 inches from insulin pump infusion set or injection site • Away from waistband, scarring, tattoos, irritation, and bones • Unlikely to be bumped, pushed, or laid on while sleeping Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Transmitter Safety Statements

WarningsInspect Don’t use a damaged or cracked transmitter. A damaged transmitter could cause injuries from electrical shocks and may make the G6 not work correctly. Use as Directed The transmitter is small and may pose a choking hazard. Don’t put it in your mouth or let children hold it without adult supervision. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

PrecautionsReuse – Don’t Throw Away When ending a session, don’t throw away the transmitter. The transmitter is reusable until the G6 notifies you that the transmitter battery is about to expire. Don’t Share Never share your transmitter. The G6 is a prescription-only medical device and is meant for your use only. The transmitter is tied to the G6 readings. If used by more than one person, the G6 readings, reports, alarm/alerts, etc., may be wrong. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

System Safety Statements

PrecautionsTreatment Decisions Use your G6 reading and trend arrow to make treatment decisions.

Use Correct Transmitter, Receiver, and Sensor G6 components are not compatible with any previous Dexcom products. Do not mix transmitters, receivers, and sensors from different generations.

Going Through Security Check Point

When wearing your G6, ask for hand-wanding or full-body pat-down and visual inspection instead of going through the Advanced Imaging Technology (AIT) body scanner (also called a millimeter wave scanner) or putting any part of the G6 in the baggage x-ray machine. You can wear the G6 for the walk-through metal detector. If you do, use your meter for treatment decisions until you leave the security area. Because we haven’t tested every x-ray and scanner, we don’t know if they damage the G6. Not sure what kind of machine it is? Be safe – either ask the TSA officer, request hand-wanding, or request full-body pat-down.

Interfering Substance Risks

In previous generations of Dexcom CGM systems (G4/G5), acetaminophen could affect your sensor readings, making them look higher than they really were. However, with the G6, you can take a standard or maximum acetaminophen dose of 1 gram (1,000mg) every 6 hours and still use the G6 readings to make treatment decisions. Taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults) may affect the G6 readings and make them look higher than they really are. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Receiver and Smart Device Safety Statements

PrecautionsKeep Transmitter Close to Display Device Keep your transmitter and display device within 20 feet with no obstacles (like walls or metal) between them. Otherwise, they might not be able to communicate. If water is between your transmitter and the display device – for example, if you’re showering or swimming – keep them closer to each other. The range is reduced because Bluetooth® doesn’t work as well through water.

Get Alarm/Alerts on Display Device You Use To get your alarm/alerts, set them on the display device you use. Your receiver won’t get the alarm/alerts you set on your app. Likewise, your app won’t get the alarm/alerts you set on your receiver.

Is It On? If the receiver or smart device is turned off (shut down), it will not show G6 readings or alarm/alerts. Make sure your display device is turned on.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Smart Device Safety Statements

Warnings

Check Settings

When using your smart device, you should confirm that your volume is turned up, your phone is not muted, and you do not have headphones plugged in. If your volume is not turned up, the device is muted, or headphones are plugged in, you will not hear the sound of any notifications, including important alarms. When you have headphones connected to your Android®, alarm/alerts will sound through the headphones and the speaker. On your Apple, they will sound only in the headphones.

Some notifications are silent during the first visual and vibrate notification and then make a sound on the second notification. If you don’t clear the alert, it repeats at half volume after 5 minutes and at full volume after 10 minutes.

Your alarm and important alerts sound and display information even when your volume is low or muted. Specifically, if your smart device is on mute, only these notifications make a sound: Glucose Alarm/Alerts: • Urgent Low • Urgent Low Soon • Low Glucose • High Glucose • Rise Rate • Fall Rate • No Readings Alert System Alerts: • Calibration Required (after 2-hour sensor warmup, only appears when a sensor code is not active) • Calibration Error (only appears when a user enters a calibration; calibration is not required) • Sensor Expired • Replace Sensor • Transmitter (not working) • No Storage Error • App Stopped There’s one exception: On Apple® devices, Signal Loss doesn’t sound when your volume is low or muted. Bluetooth: Your transmitter talks to your app with Bluetooth. Make sure your smart device Bluetooth is on. If not, you will not get alarm/alerts or CGM information. Notifications: • Make sure your smart device settings allow Dexcom app notifications to show on your Lock screen. This will allow you to see notifications without unlocking your phone. • Apple: During G6 setup, enable Dexcom app notifications or you won’t get alarm/alerts. Battery: The app must always be running in the background and may drain your smart device battery. Keep the battery charged. Compatibility: Before upgrading your smart device or its operating system, check dexcom.com/compatibility. Automatic updates of the app or your device operating system can change settings or shut down the app. Always update manually and verify correct device settings afterward. Time: Let the date and time on your smart device automatically update when you travel across time zones or switch between standard and daylight saving times. Don’t manually change your smart device time, because it can make the time on the trend screen wrong and the app may stop displaying data. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

PrecautionsCheck Peripheral Devices Do you use headphones with your smart device? What about Bluetooth speakers or a smart watch? When using peripherals, keep in mind you may get your alarm/ alerts on only one device or peripheral, not all. After connecting any peripheral devices, make sure that your smart device settings allow you to continue receiving alarms or alerts. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Receiver Safety Statements

WarningsDon’t Use if Damaged Don’t use a receiver that is damaged or cracked. A damaged receiver could cause injuries from electrical shocks and may make the G6 not work correctly. Use Cable as Directed Use USB cable only as directed, and store safely. Misuse of the USB cable can be a strangulation risk. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

PrecautionsTest Speaker and Vibrations You have to hear or feel alarm/alerts to react to them, so test your receiver speaker and vibrations regularly. To make sure the speaker and vibrations work, plug in the receiver to charge. The Speaker Test screen appears for a few seconds. Follow the directions on the screen to test the speaker and vibrations. If you hear and feel them, great! But if it doesn’t beep and vibrate – perhaps it got wet or was dropped – contact Technical Support and use your app until the receiver is fixed. Keep Clean and Dry Don’t submerge your receiver in water and don’t get dirt or water in the USB port. That could damage it. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

CautionRequires Prescription U.S. law restricts the sale of the G6 Mobile to sale by, or on the order of, a physician.

Dexcom Share Safety Statements

Important User Information

Dexcom Share (Share) lets you send your sensor information from your app to your Followers’ smart devices! Read the indications, warnings, and precautions below to find out how you can safely use this app feature.

Share and Managing Your Diabetes Safety Statements

IndicationsKeep Followers Informed Use Share to send your sensor information from your smart device to your Followers’ smart devices. Use as Secondary Notice The information on your smart device is sent directly from your G6 transmitter. After it is on your device, Share sends it to your Followers. So your Followers’ information is always older than yours. Use your current information to manage your diabetes, not your Followers’ possibly outdated information. Your Followers can use the information they get to reach out to you and support you in managing your diabetes. The information they get is not meant to be used for treatment decisions, analysis, or teaching. Followers can’t change your information.

WarningsUse Your G6 to Make Treatment Decisions

Don’t use Share information for treatment decisions, like treating for a low or dosing for a high. Use the sensor information on your G6 instead. Take HCP Advice Has your HCP given you self-monitoring tasks? Keep doing them. Having Followers doesn’t replace them. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Share Setup and Settings Safety StatementsWarningFollowers Must Follow and You Must Share You have to turn Share on to make it send your sensor information to your Followers. Followers have to download the Dexcom Follow app to see what you send. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

PrecautionsFollowers Don’t Manage Your Diabetes, You Do Don’t rely on your Followers to let you know you need to make a treatment decision. Stay on top of your diabetes management. Look at your G6 often. Respond to alarm/alerts. Don’t wait for a Follower to reach out – they may not be getting your sensor information because of a technical issue.

Check Your Smart Device and Your Followers’ Smart Devices Internet access required: Both smart devices need to be connected to the Internet to use Share. Try sending your Follower an email from your device. If your Follower gets it on their device, both smart devices are connected. Batteries charged: Make sure the smart device batteries are charged. If either your or your Followers’ smart device batteries aren’t charged, Share won’t work.

Check Followers’ Smart Devices Sounds on: Followers must keep their smart device volume on, or at least the keep vibration on, so they can hear and/or feel alarm/alerts. Smart device settings trump Follow app settings. Sharing gaps: Followers won’t get your sensor information when their smart device is off, not connected to the Internet, or in Do Not Disturb or Airplane mode. When the Followers fix those issues, they’ll start getting the current information but they won’t get the information they missed. Cell carrier supports simultaneous voice and data: Most cell service carriers support using voice and data at the same time. Check yours and have Followers check theirs. If it’s not supported, Share won’t work during phone calls. Share will restart when the call is over and send any waiting notifications.

Customize Share So Followers Can Support You Customize Share to make sure your Followers have the information they need to help you manage your diabetes. Delay feature: Your Follower won’t get notified until after the delay time you set. Not Share feature: You can stop sharing with a Follower any time by choosing Not Share. That Follower will stop getting any of your sensor information until you choose to Share again. Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Dexcom G5 Mobile Continuous Glucose Monitoring System

Indications for Use

The Dexcom G5 Mobile Continuous Glucose Monitoring System (Dexcom G5) is a glucose monitoring system indicated for the management of diabetes in persons age 2 years and older. The Dexcom G5 is designed to replace fingerstick blood glucose testing for diabetes treatment decisions.

Interpretation of the Dexcom G5 results should be based on the glucose trends and several sequential readings over time. The Dexcom G5 also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G5 is intended for single patient use and requires a prescription.

Important User Information

Failure to use the Dexcom G5 and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from your Dexcom G5 do not match your symptoms or expectations, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate.

Please review the product instructions before using the Dexcom G5. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the Dexcom G5. Discuss with your healthcare professional how you should use the information displayed on the Dexcom G5 to help manage your diabetes. The product instructions contain important information on troubleshooting the Dexcom G5 and on the performance characteristics of the system.

Contraindications

MRI/CT/ Diathermy Remove the Dexcom G5 sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The Dexcom G5 has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the components of the Dexcom G5, which may cause it to display inaccurate blood glucose readings or may prevent alerts.

The system hasn’t been tested during MRI, CT scans, or with diathermy treatment. Magnetic fields and heat could damage the components, stopping sensor glucose readings or Alarm/Alert notifications. Without sensor glucose readings or Alarm/Alert notifications, you might miss a severe low or high glucose event.

Medications Taking medications with acetaminophen while wearing the Dexcom G5 may inaccurately raise the glucose readings generated by the Dexcom G5. The level of inaccuracy depends on the amount of acetaminophen active in your body and is different for each person. Do not rely on continuous glucose monitoring (CGM) data produced by the Dexcom G5 if you have recently taken acetaminophen.

Warnings

Sensor Fractures Do not ignore sensor fractures. Sensors may fracture or detach from the sensor pod on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling, or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department at 1.888.738.3646 (toll free) or 1.858.200.0200.

Do Not Use Damaged Goods If the Dexcom G5 receiver or Dexcom G5 transmitter is damaged or cracked, do not use it. This could create an electrical safety hazard causing possible electrical shocks resulting in injury. In addition, a damaged or cracked Dexcom G5 receiver or Dexcom G5 transmitter may cause the Dexcom G5 System not to function properly.

Choking Do not allow young children to hold the sensor or transmitter without adult supervision. The sensor and transmitter include small parts that may pose a choking hazard.

The following warnings may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:

Review Training Materials Thoroughly review the training materials included with your Dexcom G5 before use. Incorrect use of the Dexcom G5 could lead you to misunderstand information produced by the system or might affect the system’s performance.

Diabetes Treatment Decisions If your Dexcom G5 does not display a sensor glucose reading and an arrow or if you are getting inaccurate or inconsistent readings, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions.

Do Not Ignore Low/High Symptoms Do not ignore symptoms of low or high glucose. If your glucose alerts and readings do not match your symptoms or expectations, you should obtain a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions or seek immediate medical attention.

Who Shouldn’t Use The Dexcom G5 Mobile CGM System was not evaluated, nor approved for the following persons:

Pregnant women

Persons on dialysis

Do not use the Dexcom G5 Mobile CGM System in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect performance of the system. Sensor glucose readings may be inaccurate in critically ill patients.

The Dexcom G5’s accuracy has not been tested in people within these groups and the system’s glucose readings may be inaccurate.

Calibrate on Schedule Calibrate the Dexcom G5 at least once every 12 hours. The Dexcom G5 needs to be calibrated in order to provide accurate readings. Do not use the Dexcom G5 for diabetes treatment decisions unless you have followed the prompts from the device and calibrated every 12 hours after the initial calibration.

Placement Do not insert the sensor component of the Dexcom G5 in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the Dexcom G5 is not approved for other sites. If placed in other areas, the Dexcom G5 may not function properly.

Initial Calibration: Data/Alarm/Alert Do not expect sensor glucose readings or Alarms/Alerts from the Dexcom G5 until after the 2-hour startup. The Dexcom G5 will NOT provide any sensor glucose readings or Alarms/Alerts until after the 2-hour startup ends AND you complete the startup calibration. Use fingerstick glucose values from your blood glucose meter during the 2-hour startup.

Sensor Storage Store the sensor at temperatures between 36°F-77°F for the length of the sensor’s shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in the freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate.

If the settings on your smart device are incorrect, your Dexcom G5 may not function properly. The Dexcom G5 Alarm/Alert vibrations are not any different from other vibrating apps on your smart device. Medical device apps, like the G5 Mobile app, do not have any special priorities over your smart device’s features. You cannot determine if a vibration is a notification from your G5 Mobile app or another app. The only way to know is to look at the screen.

Missed an Alarm or Alert? An Alarm or Alert from the G5 Mobile app cannot be heard through your smart device’s speakers if headphones are plugged in. Make sure you unplug your headphones when you are done using them, otherwise you might not hear an Alarm or Alert from the Dexcom G5.

Precautions

Sensor Package Do not use the Dexcom G5 sensor if its sterile package has been damaged or opened. Using a non-sterile sensor might cause infection.

Clean and Dry Before Using Do not open the sensor package until you have washed your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor. Do not insert the sensor until you have cleaned the skin near the insertion site with a topical antimicrobial solution, such as isopropyl alcohol, and allowed the skin to dry. Inserting into unclean skin might lead to infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better.

Reusable: Don’t Throw Away Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter’s battery life.

The following precautions may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:

Be Accurate, Be Quick To calibrate the system, enter the exact blood glucose value displayed on your blood glucose meter within five minutes of a carefully performed fingerstick glucose measurement.

Treatment Decisions Make diabetes treatment decisions based on the combination of the sensor glucose reading, trend arrow, and/or actionable alerts generated by the Dexcom G5.

Expiration Date Do not use Dexcom G5 sensors beyond their expiration date. Before inserting a sensor, confirm the expiration date that is listed on the package label in the following format: YYYY-MM-DD. Do not use sensors that are beyond their expiration date, because the sensor glucose readings might not be accurate.

Sensor Placement Avoid using the same spot repeatedly for sensor insertion. Rotate your sensor placement sites, and do not use the same site for two sensor sessions in a row. Using the same site might cause scarring or skin irritation. Avoid inserting the sensor in areas that are likely to be bumped, pushed, or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in these areas might affect sensor accuracy. Avoid injecting insulin or placing an insulin pump infusion set within three inches of the sensor. The insulin might affect sensor performance.

Use Correct Transmitter, Receiver, and Sensor Different generations of Dexcom CGM System transmitters and receivers are not interchangeable with each other. The Dexcom G5 transmitter and receiver are not compatible with the Dexcom G4 PLATINUM CGM System transmitter and receiver. The Dexcom G5 will not work if you mix the transmitter and receiver from different generations. You can use a Dexcom G4 PLATINUM sensor with the Dexcom G5 System. Before using the sensor, make sure the sensor label says “Dexcom G5 Mobile/G4 PLATINUM Sensor” or “Dexcom G4 PLATINUM Sensor.”

Communication Range Avoid separating the transmitter and receiver by more than 20 feet. The transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, shower, etc. Types of obstruction differ and have not been tested. If your transmitter and receiver are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter.

Setting Alarm/Alert Notifications When using both a receiver and a smart device with your Dexcom G5, you must set your settings separately in each. If you set up one device and then use another, you might not get an Alarm or Alert. Using an accessory device (like a smart watch) might override your smart device sounds. Alarm or Alerts might vibrate or be heard on the accessory instead of your smart device. After connecting any accessories, make sure that the smart device settings allow you to continue receiving Alarm or Alerts on the smart device.

Is It On? If the receiver or smart device is turned off (Shut Down), it will not display sensor data, information, Alarm or Alerts generated by the Dexcom G5. Make sure the display devices are turned on; otherwise you won’t get sensor glucose readings or Alarm or Alerts.

Keep Receiver Dry Keep the USB port cover on the receiver closed whenever the USB cable is not attached. Do not submerge the receiver in water. If water gets into the USB port, the receiver could become damaged and stop displaying readings or providing alerts.

No Alternative Site Testing Do not use alternative site blood glucose testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different from those taken from a fingerstick blood glucose test and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Using alternative site blood glucose values for calibration might affect Dexcom G5 accuracy.

When Not to Calibrate Do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling. Calibrating during rapid rise or fall of blood glucose may affect sensor accuracy.

Don’t Share Your Transmitter Do not share your transmitter with another person or use a transmitter from another person. The Dexcom G5 is a prescription-only medical device and is meant, or indicated, for individual use only. The transmitter is tied to the sensor glucose readings. If the transmitter is used by more than one person, the glucose readings, alerts, and reports may be wrong.

CAUTION

U.S. law restricts the sale of the Dexcom G5 Mobile CGM System to sale by or on order of a physician.

Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring

INDICATIONS FOR USE

The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes. The system is intended for single patient use and requires a prescription.

The Dexcom G4 PLATINUM (Pediatric) System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

The Dexcom G4 PLATINUM (Pediatric) System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom G4 PLATINUM (Pediatric) System results should be based on the trends and patterns seen with several sequential readings over time.

IMPORTANT USER INFORMATION

Please review your product instructions before using your continuous glucose monitoring system. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in your product instructions. Discuss with your healthcare professional how you should use your sensor trend information to help manage your diabetes. Your product instructions contain important information on troubleshooting your system and on the performance characteristics of the device.

CONTRAINDICATIONS

Remove the Dexcom G4 PLATINUM sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The device is MR Unsafe. Do not bring any portion of the device into the MR environment. The Dexcom G4 PLATINUM (Pediatric) System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value.

Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.

WARNINGS

Do not use the Dexcom G4 PLATINUM (Pediatric) CGM System until you have thoroughly reviewed the training materials. Incorrect use might lead you to misunderstand the CGM information or affect system accuracy. This could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not use the Dexcom G4 PLATINUM (Pediatric) System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM (Pediatric) System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not ignore symptoms of high and low glucose. If your sensor glucose alerts and readings do not match your symptoms, measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range. Solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decision.

In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on CGM alerts to detect low glucose.

Do calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate and glucose alerts to become unreliable. This could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not ignore sensor fractures. Sensors may fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department at 1.877.339.2664 or 1.858.200.0200.

Do not use the Dexcom G4 PLATINUM (Pediatric) System in pregnant women or persons on dialysis. The system is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations. Sensor glucose readings may be inaccurate in these populations and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not use the Dexcom G4 PLATINUM (Pediatric) System in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Sensor glucose readings may be inaccurate in critically ill patients, and solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not insert the sensor in sites other than the belly (abdomen) or upper buttocks. Other sites have not been studied and are not approved. Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not expect alerts from the Dexcom G4 PLATINUM (Pediatric) System until after the 2-hour startup. You will NOT get any sensor glucose readings or alerts until after the 2-hour startup ends AND you complete the startup calibration. During this time you might miss severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not use your transmitter or receiver if it is damaged/cracked. This could create an electrical safety hazard or malfunction, which might cause electrical shocks.

Store the sensor at temperatures between 36° F - 77° F for the length of the sensor’s shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in a freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate, and you might miss severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not allow young children to hold the sensor, transmitter or transmitter kit box without adult supervision. The sensor and transmitter include small parts that may pose a choking hazard. Keep the transmitter kit box away from young children; it contains a magnet that should not be swallowed.

PRECAUTIONS

Do not open the sensor package until you have washed your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.

Do not insert the sensor until you have cleaned the skin with a topical antimicrobial solution, such as isopropyl alcohol, and allowed the skin to dry. Inserting into unclean skin might lead to infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better.

Avoid using the same spot repeatedly for sensor insertion. Rotate your sensor placement sites, and do not use the same site for two sensor sessions in a row. Using the same site might cause scarring or skin irritation.

Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in those areas might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of the sensor. The insulin might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might cause infection.

Do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling. Calibrating during significant rise or fall of blood glucose may affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

The system accuracy may be affected when your glucose is changing at a significant rate (e.g., 2-3 mg/dL/min or more than 3 mg/dL each minute), such as during exercise or after a meal.

Avoid separating the transmitter and receiver by more than 20 feet. The transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, or on a water bed, etc. Types of obstruction differ and have not been tested. If your transmitter and receiver are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Keep the USB port cover on the receiver closed whenever the USB cable is not attached. If water gets into the USB port, the receiver could become damaged and stop displaying readings or providing alerts and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor accuracy and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life.

The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible with the SEVEN/SEVEN PLUS Transmitter and Receiver. Different generations will not connect with each other and will not work. Also make sure to use the correct version of Dexcom STUDIO with your system.

CAUTION

U.S. (Federal) law restricts the sale of the Dexcom G4 PLATINUM (Pediatric) System to sale by or on order of a physician.

Dexcom G4 PLATINUM Continuous Glucose Monitoring

INDICATIONS FOR USE

The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription.

The Dexcom G4 PLATINUM System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

The Dexcom G4 PLATINUM System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom G4 PLATINUM System results should be based on the trends and patterns seen with several sequential readings over time.

IMPORTANT USER INFORMATION

Please review your product instructions before using your continuous glucose monitoring system. Contraindications, warnings, precautions, cautions, and other important user information can be found in your product instructions. Discuss with your healthcare professional how you should use your sensor trend information to help manage your diabetes. Your product instructions contain important information on troubleshooting your system and on the performance characteristics of the device.

CONTRAINDICATIONS

Remove the Dexcom G4 PLATINUM sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The device is MR Unsafe. Do not bring any portion of the device into the MR environment. The Dexcom G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value.

Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.

WARNINGS

Thoroughly review the training materials included with your CGM system before using the Dexcom G4 PLATINUM CGM System. Incorrect use might lead to you misunderstanding the information provided by your system, or might affect system performance, and you might miss a low or high blood glucose value.

Do not use the Dexcom G4 PLATINUM System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Using the sensor glucose readings for treatment decisions could lead to low or high blood glucose value.

Do not ignore symptoms of high and low glucose. If your sensor glucose readings do not match your symptoms, measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range, so you do not miss a low or high blood glucose value.

Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value.

Sensors may fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department at 1.877.339.2664 or 1.858.200.0200.

The Dexcom G4 PLATINUM System is not approved for use in children or adolescents, pregnant women or persons on dialysis.

It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Therefore, the use of this system in the critically ill population is not recommended.

Sensor placement and insertion is not approved for sites other than the belly (abdomen).

If your transmitter or receiver case is damaged/cracked, do not use it. This could create an electrical safety hazard or malfunction, which might cause electrical shocks.

Store the sensor at temperatures between 36° F - 77° F for the length of the sensor’s shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in a freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value.

PRECAUTIONS

Before opening the sensor package, wash your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.

Before inserting the sensor, clean the skin with a topical antimicrobial solution, such as isopropyl alcohol, and allow to dry. This may help prevent infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better.

Change the site where you place the sensor with each insertion. Using the same site too often might not allow the skin to heal, and might cause scarring or skin irritation.

Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in those areas might affect sensor performance, and you might miss a low or high blood glucose value.

Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of the sensor. The insulin might affect sensor performance, and you might miss a low or high blood glucose value.

Do not use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might cause infection.

To calibrate the system, enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Entering incorrect blood glucose values or blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might miss a low or high blood glucose value.

Do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute. Do not calibrate when your receiver screen is showing the rising single arrow or double arrow, which indicates that your blood glucose is rising 2-3 mg/dL/min or more than 3 mg/dL/min. Also, do not calibrate when your receiver screen is showing the falling single arrow or double arrow, which indicates that your blood glucose is falling 2-3 mg/dL/min or more than 3 mg/dL/min. Calibrating during significant rise or fall of blood glucose may affect accuracy of sensor glucose readings.

The system accuracy may be affected when your glucose is changing at a significant rate (e.g., 2-3 mg/dL/min or more than 3 mg/dL each minute), such as during exercise or after a meal.

The transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, or on a water bed, etc. Types of obstruction differ and have not been tested. If your transmitter and receiver are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and you might miss a low or high blood glucose value.

Keep the USB port cover on the receiver closed whenever the USB cable is not attached. If water gets into the USB port, the receiver could become damaged and stop displaying readings or providing alerts, and you might miss a low or high blood glucose value.

Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor performance, and you might miss a low or high blood glucose value.

Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life.

The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible with the SEVEN/SEVEN PLUS Transmitter and Receiver. Different generations will not connect with each other and will not work. Also make sure to use the correct version of Dexcom Studio with your system.

CAUTION

U.S. (Federal) law restricts the sale of the Dexcom G4 PLATINUM System to sale by or on order of a physician.

Dexcom Share Secondary Displays Safety Statement

Intended use

The purpose of Dexcom Share Direct Secondary Displays is to notify another person, the Follower, of the patient’s Dexcom G4 PLATINUM Continuous Glucose Monitoring System sensor glucose information. The Secondary Displays is intended for providing secondary notification of a continuous glucose monitoring system and does not replace real time continuous glucose monitoring (G4 PLATINUM System) or standard home blood glucose monitoring. The Dexcom Share Direct Secondary Displays is not intended to modify or analyze data received from the continuous glucose monitor system. Nor is it intended to instruct, or to transmit information to the continuous glucose monitor system. The Dexcom Share Direct Secondary Displays is not intended to serve as a replacement for a primary display device for a continuous glucose monitoring system. The Dexcom Share Direct Secondary Displays is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.

Important User Information

Please review the indications, contraindications, warnings, precautions, cautions and other important information in the Dexcom G4 PLATINUM System User’s Guide. Dexcom Share is a feature of the Dexcom G4 PLATINUM System. If you do not have the Dexcom G4 PLATINUM System User’s Guide, you can view it on www.dexcom.com or call 1.877.339.2664 to request a copy. Availability hours: Monday-Friday, 6am-6pm PST. Please contact your healthcare professional during hours the line is unavailable.

Contraindications

Do not bring the Dexcom G4 PLATINUM Receiver with Share, iPhone, or iPod touch into a room containing medical equipment such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or diathermy. The Dexcom Share System has not been tested with this equipment. Exposure to these types of equipment could heat and damage the receiver, iPhone, or iPod touch so that they are unable to send or receive glucose information.

Warnings

Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system.

This device is not intended to replace self-monitoring practices advised by a physician.

Dexcom Share does not work alone. Dexcom Share does not replace the Dexcom G4 PLATINUM System and requires Share to be turned “On” on the Dexcom G4 PLATINUM Receiver with Share to communicate glucose information to the Follower. Dexcom Share is not compatible with any previous Dexcom CGM System or any other CGM device.

You cannot use Dexcom Share to make treatment decisions, such as how much insulin to take. Dexcom Share does not replace a blood glucose meter. Always use the values from a blood glucose meter for treatment decisions. Blood glucose values may differ from the sensor glucose information. Using the sensor glucose information for treatment decisions could lead to low or high blood glucose values.

Precautions

Do not use Dexcom Share as the main source of CGM glucose trend information. Use the Dexcom G4 PLATINUM Receiver as the main device to track sensor glucose information, notifications and alarms. At times, the patient will be unable to share data using Dexcom Share, and the Follower might miss helping the patient in the event of low or high blood glucose values. Do not rely solely on the Follower to alert the patient of low or high glucose events or other important information. At times, the Follower may not receive data, and the patient will not be notified of this fact. When using Dexcom Share, make sure the Dexcom G4 PLATINUM Receiver with Share has Share turned “On”. If not, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values. You cannot use Dexcom Share unless there is a Bluetooth connection between the receiver with Share and the patient’s iPhone or iPod touch. The Bluetooth range can vary and depends on the distance and obstructions between the receiver and the iPhone or iPod touch. If the patient’s iPhone or iPod touch does not have a connection or loses the connection, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values.

Do not use Dexcom Share unless both the patient’s and Follower’s iPhone or iPod touch have active Internet connections in order to share data. If either the patient or the Follower does not have a connection, loses their connection, turns off the connection (“Airplane Mode”) or if either the iPhone or iPod touch is in Do Not Disturb mode, the patient will be unable to share data and the Follower might miss helping the patient in the event of low or high blood glucose values. To check this, make sure that the Follower’s iPhone or iPod touch can receive text messages. Follow notifications and text messages work by a similar process on iPhone or iPod touch.

Make sure the patient’s and Follower’s iPhone or iPod touch have charged batteries or are connected to electrical outlets. If the iPhone or iPod touch shuts down due to low battery, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values.

If the patient’s iPhone or iPod touch is powered off or restarted, make sure the Dexcom Share2 app is reopened after the iPhone or iPod touch is turned back on in order to resume sharing. If the Dexcom Share2 app is not reopened, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values.

Do not turn off system sounds in the Follower’s iPhone or iPod touch at any time that he or she wants Follow notifications to be heard. The iPhone or iPod touch settings override the Dexcom Follow app, and all notifications will be silent even if the Follower has selected a Dexcom Follow app notification sound. If the iPhone or iPod touch is on vibrate, the Dexcom Follow app notifications will only vibrate.

Check the delay settings on the patient’s iPhone or iPod touch to make sure they are not too long. The Follower will not receive notifications until after the time period in the delay has passed, and the Follower might miss helping the patient in the event of low or high blood glucose values if the delay is too long.

The patient should not choose to “Not Share” with the Follower at any time when he or she wants the Follower to get notifications. During the time the patient chooses to “Not Share”, the Follower will not receive notifications and might miss helping the patient in the event of low or high blood glucose values.

Check the Dexcom Follow app’s trend graph if the Follower’s iPhone or iPod touch has been off or if there is no data connection (e.g., Internet/wi-fi or mobile data service/3G/4G/LTE is lost, connection is turned off in Airplane Mode, or iPhone or iPod touch is placed in Do Not Disturb mode). When the iPhone or iPod touch is turned back on, the Follower will only receive the most recent notification and might miss helping the patient in the event of prior low or high blood glucose values.

Sharers and Followers should check whether their cellular service carriers support voice and data at the same time (simultaneous voice and data). If their carriers do not support simultaneous voice and data, the Dexcom Share2 app may not be able to share glucose readings and the Dexcom Follow app may not be able to receive notifications or glucose readings during phone calls. Dexcom Share will resume sharing after the phone call has ended, and the Follower will receive any waiting notifications after the phone call has ended.

SEVEN PLUS Continuous Glucose Monitoring

Indication for use

The SEVEN PLUS Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The SEVEN PLUS System is intended for use by patients at home and in health care facilities. The device is for prescription use only.

The SEVEN PLUS Continuous Glucose Monitoring System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

The SEVEN PLUS Continuous Glucose Monitoring System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the SEVEN PLUS System results should be based on the trends and patterns seen with several sequential readings over time.

Contraindications

The SEVEN PLUS System must be removed prior to Magnetic Resonance Imaging (MRI).

Use of acetaminophen-containing medications while the SEVEN Sensor is inserted may affect the performance of the device.

Warnings

This device is not designed to replace a blood glucose meter. The SEVEN PLUS must be used with a blood glucose meter.

Treatment decisions should not be based solely on results from the SEVEN PLUS. You must confirm with a blood glucose meter before making therapeutic adjustments.

Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use your blood glucose meter to check the SEVEN PLUS results.

You should update the SEVEN PLUS’ calibration every 12 hours at a minimum. The performance of the SEVEN PLUS System when calibrated less frequently than every 12 hours has not been studied.

Sensors fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department.

The SEVEN and SEVEN PLUS Systems are not approved for use in children or adolescents, pregnant women or persons on dialysis.

The safety and effectiveness of the SEVEN and SEVEN PLUS Systems have not been evaluated for sensor probe insertion sites other than the skin of the abdomen.

Precautions

Always wash hands with soap and water before opening the Sensor package. After opening the package, avoid touching the adhesive area.

Before inserting the Sensor, always clean the skin at the Sensor insertion location with a topical antimicrobial solution such as isopropyl alcohol. Do not apply the Sensor until the cleaned area is dry.

Establish a rotation schedule for choosing each new Sensor location. Avoid Sensor locations that are constrained by clothing, accessories, or subjected to rigorous movement during exercise.

Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of a Sensor.

The Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if its sterile package has been previously damaged or opened.

For OpenChoice Calibration you must enter the exact fingerstick reading that your blood glucose meter displays. Enter all fingerstick readings for calibration within 5 minutes. Entering incorrect fingerstick readings that occurred more than 5 minutes ago will affect device performance.

Please note, the performance characteristics section of the SEVEN PLUS User’s Guide has changed to reflect the recent study done. The overall results of the trial showed that SEVEN PLUS System will provide you more continuous glucose readings, and you should expect more of your Sensors to provide data for the entire 7-day use period. Note that the data described in the Performance Section also showed a difference from the SEVEN PLUS to the original SEVEN device in performance in the low glucose region (40-80 mg/dL). Our study showed that at 50 mg/dL blood glucose, the device reported glucose to be as high as 64 mg/dL and at 80 mg/dL blood glucose; the device reported glucose to be as high as 90 mg/dL. Because the performance of the SEVEN PLUS System varies from the original, it is important that you assess how the new generation device performs for you, especially in the low range. You should review the performance of this device with your healthcare provider to understand how well the SEVEN PLUS System performs.

Dexcom CLARITY Continuous Glucose Monitoring Software

Indications for use

The web-based Dexcom CLARITY® software is intended for use by both home users and healthcare professionals to assist people with diabetes in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities.

Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software.

Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them.

Dexcom STUDIO Continuous Glucose Monitoring Software

Indications for use

The Dexcom Studio Data Manager software is an accessory software program intended to allow the transfer of glucose data stored by the Dexcom Continuous Glucose Monitoring System into a personal computer (PC). The software can be used by either a clinician or an end user.

WARNING: This software does not provide any medical advice and may not be relied upon for that purpose. Do not make fundamental changes in your treatment program without talking to your healthcare professionals.